BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM

    MDR report key: 2955038 · Received February 11, 2013

    Report

    Report Number
    3004209178-2013-02495
    Event Type
    Injury
    Date Received
    February 11, 2013
    Report Date
    January 22, 2013
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 3889-28, LOT# J0428161V, PRODUCT TYPE LEAD; PRODUCT ID 3095-10, SERIAL# (B)(4), PRODUCT TYPE EXTENSION; PRODUCT ID 3031A, SERIAL# UNKNOWN, PRODUCT TYPE PROGRAMMER, PATIENT. (B)(4).

    Description of Event or Problem · 1

    WHEN CONTACTED FOR FOLLOW UP INFORMATION, THE PHYSICIAN REPORTED THAT THEY HAD NOT SEEN THE PATIENT IN OVER 5 YEARS AND NOTED THAT THEIR RECORDS HAD BEEN DESTROYED. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP REPORT WILL BE SENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT HAD AN INFECTION FOR THE PAST THREE DAYS PRIOR TO THE REPORT. THE REPORTER STATED THAT THERE WAS A LOSS OF THERAPEUTIC EFFECT FOR THE PAST THREE WEEKS BEFORE THE REPORT. THE NEXT DAY, IT WAS REPORTED THAT THE PATIENT FELT NO STIMULATION SENSATION AND HAD NOT FELT STIMULATION FOR THREE TO FOUR WEEKS. THE REPORTER STATED THAT THE PATIENT WAS GOING TO THE BATHROOM MORE AND THE DEVICE 'WAS DEAD' AND NEEDED TO BE REPLACED. IT WAS REPORTED THAT THE PATIENT WAS ABLE TO TURN THE DEVICE ON AND INCREASE STIMULATION. THE REPORTER STATED THAT THE PATIENT COULD FEEL STIMULATION. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    58278 INTERSTIM STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3023

    Patients

    Seq Age Sex Outcome Treatment
    1 00062 YR Required Intervention